Appendix Table

• Author: Kenneth Dorsney
• Pages: 660-661

Left column Right column

  A B C D E F G

  1231231231231234561234567

(1) Drugs with new active ingredients     ×  

(2) New prescription combination preparations ×            ×  ××××

(3) Drugs with new routes of administration ×            ×  ×  

(4) Drugs with new indications ××××××× ×  ××××××××

(5) Drugs with new formations ××××    ××××××××

(6) Drugs with new dosages ××××××× ×     ××××××××

(7) Biosimilars   × ×  ×  ×××  

(8) Drugs to undergo additional formulations

(those undergoing reexamination) ×    ××××××××××××××××

(8-2) Drugs to undergo additional formulations (those not

undergoing reexamination)

(9) Prescription combination preparations with similar

compositions (those undergoing reexamination) ×  ×××××××××××

(9-2) Prescription combination preparations with similar

compositions (those not undergoing reexamination)

(10) Other types of drugs (those undergoing

reexamination)

××××× × ××××××××××××××××

(10-2)

Other types of drugs (in the case of drugs in (10),

those undergoing change of manufacturing methods

of biological preparations, etc.)

(10-3) Other types of drugs (those not undergoing

reexamination)

(10-4)

Other types of drug (in the case of the drugs in

(10-3), those undergoing change of manufacturing

methods of biological preparations, etc.)

Notes:

×: Not necessary

: Necessary

: Necessity shall be judged for each individual item

The codes and numbers shown in the right column correspond to the codes and numbers of documents set forth in the chart below.

Appendix Table1

1. MHLW notification Yakushoku-hatsu No. 331015, issued Mar. 31, 2005, amended by

MHLW notification Yakushoku-hatsu No. 0304004, issued Mar. 4, 2009.

Documents Required for Application for Approval of Prescription Drugs

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